Spots Global Cancer Trial Database for A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer

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Trial Identification

Brief Title: A Study of OBP-301 With Radiation Therapy in Patients With Esophageal Cancer

Official Title: A Phase 1 Study to Evaluate the Safety of OBP-301, Telomelysin in Combination With Radiation Therapy in Patients With Esophageal Cancer Not Applicable for Standard Therapy

Study ID: NCT03213054

Conditions

Esophageal Cancer

Interventions

OBP-301

Radiation

Study Description

Brief Summary: This is a phase 1 study to evaluate safety and tolerability of Telomelysin (OBP-301) in combination with radiation therapy in patient with esophageal cancer who are not applicable to standard therapy.

Detailed Description: After screening, patients will undergo a combination therapy of OBP-301 with radiation therapy for 6 weeks. At Day 1, Day 18 and Day 32, OBP-301 is directly injected to the location of the lesion. From Day 4, patients receive radiation therapy. Patients will be automatically entered follow-up period for 12 weeks to be observed tolerance and safety. This study is designated as standard 3 + 3 dose escalation study. The first 3 patients will be evaluated with low-dose of OBP-301 and then the study move onto the high-dose cohort of OBP-301. When the DLT (Dose Limiting Toxicity) is observed, 3 more patients will be enrolled in the dose level.